APO-RA: Tolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid Arthritis

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT02903212

Collaborator

(none)

Enrollment

Arm

21.1

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The aim of the study is to determine the tolerance of apoptotic autologous cells injection in subjects with active rheumatoid arthritis.

Condition or Disease	Intervention/Treatment	Phase
Arthritis, Rheumatoid	Biological: Autologous apoptotic cells injection	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

22 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Tolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid Arthritis

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rheumatoid arthritis Patients with rheumatoid arthritis. An injection of autologous apoptotic cells is performed on the D0.	Biological: Autologous apoptotic cells injection cells injection

Arm

Intervention/Treatment

Experimental: Rheumatoid arthritis

Patients with rheumatoid arthritis. An injection of autologous apoptotic cells is performed on the D0.

Biological: Autologous apoptotic cells injection

cells injection

Outcome Measures

Primary Outcome Measures

Tolerance of apoptotic cells injection [12 weeks]
Side effects are taken into account to assess tolerance.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with a diagnosis of Rheumatoid arthritis
Therapy failure with at least one biological agent from anti-TNF-alpha (etanercept, infliximab, adalimumab, certolizumab and golimumab; 3 months at optimal dose), anti-IL6 (tocilizumab; 3 months); T-cell costimulatory pathway inhibitor (abatacept; 3 months); anti-CD20 (rituximab; 6 months at optimal dose); Anti IL-1 (anakinra; 3 months)
Disease Activity Score (DAS) DAS28 ≥ 3.2
Subject has provided written informed consent

Exclusion Criteria:

Pregnant or lactating women
Inflammatory arthritis other than rheumatoid arthritis
History of invasive cancer
Immunodeficiency (HIV infection, Immunosuppressive therapy)
Active bacterial or viral infections, in particular HCV or HBV.
Surgery not older than 4 weeks.
Unstable comorbidities: uncontrolled diabetes, heart disease, advanced renal or hepatic impairment.
Contraindication to an apheresis

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Centre Hospitalier Universitaire de Besancon

Investigators

Principal Investigator: Eric Toussirot, Professor, Rhumatology - CHU Besançon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Besancon

ClinicalTrials.gov Identifier:

NCT02903212

Other Study ID Numbers:

P/2013/196

First Posted:

Sep 16, 2016

Last Update Posted:

Apr 6, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire de Besancon

Apoptotic cells

Additional relevant MeSH terms:

Arthritis

Arthritis, Rheumatoid

Study Results

No Results Posted as of Apr 6, 2022